OMEGA NV(TM) BALLOON DILATATION CATHETER
Device Facts
| Record ID | K882052 |
|---|---|
| Device Name | OMEGA NV(TM) BALLOON DILATATION CATHETER |
| Applicant | Cook, Inc. |
| Product Code | LIT · Cardiovascular |
| Decision Date | Sep 14, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.
